PMID- 35834107
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220824
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 13
IP  - 9
DP  - 2022 Sep
TI  - Impact of Partial Meal Replacement on Glycemic Levels and Body Weight in Indian 
      Patients with Type 2 Diabetes (PRIDE): A Randomized Controlled Study.
PG  - 1599-1619
LID - 10.1007/s13300-022-01294-0 [doi]
AB  - INTRODUCTION: Partial meal replacement (PMR) offers potential glycemic and weight 
      control benefits in type 2 diabetes mellitus (T2DM) patients. We evaluated the 
      clinical impact of PMR (diabetes-specific nutritional supplement [DSNS]) in 
      overweight/obese Indian patients with T2DM. METHODS: PRIDE, a 12-week, phase IV, 
      open-label, multicenter study randomized (1:1) newly diagnosed T2DM patients 
      (</= 1 year) to either DSNS plus standard of care (SOC; diabetes treatment with 
      dietary counseling) group (PMR) or SOC alone group (SOC). The primary endpoint 
      was mean change in glycated hemoglobin (HbA1c) from baseline to week 12. 
      Secondary endpoints were changes in glucose profiles, body weight, waist 
      circumference, lipid profile, and factors impacting quality-of-life (QoL) at week 
      6 and 12 from baseline. Safety was assessed throughout the study. RESULTS: Of the 
      176 patients enrolled, 171 (n = 85 in PMR group; n = 86 in SOC group) were 
      included in the modified intent-to-treat population. The mean reduction in HbA1c 
      at week 12 from baseline in PMR group was significant compared to the SOC group 
      (- 0.59 vs. - 0.21%, p = 0.002). At week 12, the PMR group showed significant 
      reduction in mean body weight (- 2.19 vs. - 0.22 kg; p = 0.001) and waist 
      circumference (- 2.34 vs. - 0.48 cm; p = 0.001) compared to SOC group. Mean 
      fasting plasma glucose and post-prandial glucose significantly reduced from 
      baseline at week 6 and 12 in each group (p < 0.05). No significant change was 
      observed in lipid profile. QoL parameters (treatment adherence, general 
      well-being, and energy fulfilment) in the PMR were significantly better than SOC 
      group (p < 0.05). Patients were satisfied with the taste of DSNS. No serious 
      adverse events were reported. CONCLUSIONS: DSNS is an encouraging option for PMR 
      strategy, as it significantly improved HbA1c, body weight, waist circumference, 
      and overall well-being among overweight/obese Indian T2DM patients. TRIAL 
      IDENTIFICATION NO: CTRI/2019/10/021595.
CI  - (c) 2022. The Author(s).
FAU - Dharmalingam, Mala
AU  - Dharmalingam M
AD  - Endocrinology and Diabetes Research Center and Laboratory, Bangalore, 560003, 
      India.
FAU - Das, Rupam
AU  - Das R
AD  - Downtown Hospital, Guwahati, 781006, India.
FAU - Jain, Sandeep
AU  - Jain S
AD  - Marudhar Hospital, Jaipur, Rajasthan, 302012, India.
FAU - Gupta, Sachin
AU  - Gupta S
AD  - Shubham Multispeciality Hospital, Amraiwadi, Ahmedabad, 380026, India.
FAU - Gupta, Manoj
AU  - Gupta M
AD  - Health Point Hospital, Kolkata, 700025, India.
FAU - Kudrigikar, Vinay
AU  - Kudrigikar V
AD  - India Medical Affairs, Sun Pharma Laboratories Ltd., Sun House, Plot No. 201 8/1, 
      Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India. 
      vinay.kudrigikar@sunpharma.com.
FAU - Bachani, Deepak
AU  - Bachani D
AD  - India Medical Affairs, Sun Pharma Laboratories Ltd., Sun House, Plot No. 201 8/1, 
      Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India.
FAU - Mehta, Suyog
AU  - Mehta S
AD  - India Medical Affairs, Sun Pharma Laboratories Ltd., Sun House, Plot No. 201 8/1, 
      Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India.
FAU - Joglekar, Sadhna
AU  - Joglekar S
AD  - India Medical Affairs, Sun Pharma Laboratories Ltd., Sun House, Plot No. 201 8/1, 
      Western Express Highway, Goregaon (E), Mumbai, Maharashtra, 400063, India.
LA  - eng
SI  - CTRI/CTRI/2019/10/021595
PT  - Journal Article
DEP - 20220714
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC9281377
OTO - NOTNLM
OT  - Body weight
OT  - Diabetes-specific nutritional supplement
OT  - Glycemic control
OT  - India
OT  - Partial meal replacement
OT  - Quality of life
OT  - Type 2 diabetes mellitus
EDAT- 2022/07/15 06:00
MHDA- 2022/07/15 06:01
PMCR- 2022/07/14
CRDT- 2022/07/14 11:21
PHST- 2022/04/11 00:00 [received]
PHST- 2022/06/21 00:00 [accepted]
PHST- 2022/07/15 06:00 [pubmed]
PHST- 2022/07/15 06:01 [medline]
PHST- 2022/07/14 11:21 [entrez]
PHST- 2022/07/14 00:00 [pmc-release]
AID - 10.1007/s13300-022-01294-0 [pii]
AID - 1294 [pii]
AID - 10.1007/s13300-022-01294-0 [doi]
PST - ppublish
SO  - Diabetes Ther. 2022 Sep;13(9):1599-1619. doi: 10.1007/s13300-022-01294-0. Epub 
      2022 Jul 14.